The Effect-site Concentration of Remifentanil Blunting Endotracheal Intubation Responses During Anesthesia Induction With Lidocaine or Sufentanil Combined With Etomidate: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- The 50% effective effect-site target concentration (EC₅₀) of remifentanil for suppressing patients' tracheal intubation response
研究概览
简要总结
The aim of this study was to compare the effect-site target concentration (including EC₅₀ and EC₉₀) of remifentanil required to suppress cardiovascular responses to tracheal intubation during anesthesia induction with etomidate combined with either lidocaine or sufentanil.
详细描述
This study is a single-center, randomized controlled trial utilizing a modified sequential method to determine the effect site target concentration of remifentanil, including the median effective concentration (EC₅₀) and the 90% effective concentration (EC₉₀). The study population consists of ASA class I-II patients undergoing general anesthesia with endotracheal intubation. Patients will be randomly assigned to one of three groups: placebo group, lidocaine group, and sufentanil group. Patients in each group will receive anesthesia induction with a combination of either saline, lidocaine, or sufentanil along with etomidate, followed by target-controlled infusion of remifentanil. The primary outcome measure is the median effective target concentration of remifentanil in the effect site (EC₅₀) for suppressing the intubation response. Secondary outcomes include the 90% effective target concentration of remifentanil (EC₉₀), changes in mean arterial pressure (MAP), heart rate (HR), and bispectral index (BIS) before and after intubation. Each group is expected to enroll 33 patients, totaling 99 patients across all three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for elective surgery under general anesthesia with endotracheal intubation;
- •Classified as ASA physical status I-II.
排除标准
- •Age <18 years or >65 years;
- •Body mass index (BMI) >30 kg/m² or <18.5 kg/m²;
- •Diagnosis of hypertension or severe cardiovascular diseases (including myocardial infarction, heart failure, atrial fibrillation, atrioventricular block, moderate-to-severe valvular diseases) or respiratory diseases (including acute exacerbation of chronic obstructive pulmonary disease, acute respiratory distress syndrome, acute asthma attack, moderate-to-severe pulmonary hypertension, severe pneumonia);
- •Diagnosis of obstructive sleep apnea syndrome or history of difficult intubation or preoperatively anticipated difficult airway;
- •Renal, hepatic or hematologic diseases;
- •High risk of aspiration or reflux;
- •Current use of analgesics for chronic pain or β-blockers for cardiovascular diseases;
- •Current use of psychotropic medications;
- •Contraindications to remifentanil or sufentanil, including: known hypersensitivity to any component of these drugs or other fentanyl analogues, current use of monoamine oxidase inhibitors, myasthenia gravis or conditions predisposing to respiratory depression, bronchial asthma or related disorders;
- •Contraindications to lidocaine, including: known allergy to local anesthetics, concurrent Adams-Stokes syndrome, Wolff-Parkinson-White syndrome, or severe cardiac conduction block.
研究组 & 干预措施
placebo group
干预措施: Intravenous normal saline (NS 0.9) (Drug)
sufentanil group
干预措施: intravenous sufentanil (Drug)
lidocaine group
干预措施: Intravenous lidocaine (Drug)
结局指标
主要结局
The 50% effective effect-site target concentration (EC₅₀) of remifentanil for suppressing patients' tracheal intubation response
时间窗: Through study completion, an average of 1 year.
次要结局
- The 90% effective effect-site target concentration (EC₉₀) of remifentanil for suppressing patients' tracheal intubation response(Through study completion, an average of 1 year.)
- complications(Operative day, Postoperative day 1, Postoperative day 5.)